Surgical threading device and method for using same

ABSTRACT

Described herein is a threading device that includes an elongated rod having first and second opposite ends, and a suture having first and second opposite ends. The first end of the suture is associated with the rod. The rod is at least partially covered with a coating that secures the first end of the suture to the rod. The second end of the suture extends outside the coating. This provides a threading rod having a suture permanently attached thereto.

This application is a continuation-in-part of application Ser. No.11/950,401, filed Dec. 4, 2007 now U.S. Pat. No. 7,833,233, which is acontinuation-in-part of application Ser. No. 11/566,618, filed Dec. 4,2006 which is now U.S. Pat. No. 7,566,340, the entireties of which areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to methods and devices forplastic surgery and, more particularly, to a necklift procedure that isminimally invasive and to instruments for performing the procedure.

BACKGROUND OF THE INVENTION

Conventional neck rejuvenation surgeons advocate procedures that alterthe anatomy of the neck to restore a more youthful neck contour. Theseinvolve platysmal manipulation such as muscle advancement and/ordivision, and frequently sub-platysmal fat excision. Partial resectionof submandibular gland tissue may be performed as well. These techniquesvary in complexity and may result in significant complications,including post-operative bleeding, nerve injury, permanent visible skindeformities caused by muscle division, or over-resection of fat.

Plastic and reconstructive surgeons have long sought to develop methodsand devices to aid in the support of physical structures that have losttheir natural tension and support. The most often treated areas includethe face, the chest region, the buttocks and other regions that losetension and sag. Current devices are not always adequate in providing anatural-looking structure to prevent such loss of tension in thesestructures.

The aging process causes gradual and predictable changes in the softtissue layers of the lower face and neck, the anatomical basis of whichhas been well documented. Loss of elasticity and fragmentation ofcollagen results in rhytid formation and skin redundancy. Subcutaneousfat thickens and droops or is ptotic and becomes more noticeable.Stretching of the fascia and musculature results in a loss of thesupporting ‘sling’ of the submentum, often resulting in submandibulargland ptosis. Further loss of tone and muscular atrophy results inbanding of the medial platysmal borders, blunting of the cervicomentalangle and loss of lateral mandibular definition.

The classical necklift's failure in adequately addressing theconsequences of aging in the neck has prompted the development of anumber of modifications and adjunctive procedures. These include skinexcisions, various lipoplasty techniques, anterior or posteriorly basedplatysmal transection, resection, or plication procedures, SMAS-platysmaflaps, and even suture suspension techniques. However, thesemodifications have their limitations.

Problems with scar contractures and hypertrophic scarring have resultedin the near abandonment of midline skin excision with subsequent Z, W orT-plasty. Liposuction or direct lipocontouring plays an important rolein the aging neck.

SUMMARY OF THE PREFERRED EMBODIMENTS

In accordance with a first aspect of the present invention, there isprovided a threading device that includes an elongated rod having firstand second opposite ends, and a suture having first and second oppositeends. The first end of the suture is associated with the rod. The rod isat least partially covered with a coating that secures the first end ofthe suture to the rod. The second end of the suture extends outside thecoating. This provides a threading rod having a suture permanentlyattached thereto. In a preferred embodiment, the elongated rod includesa channel defined therein that receives a tube. The first end of thesuture is received and secured within the tube, and the coating securesthe tube in the channel. The first end of the suture is secured in thetube by crimping a portion of the tube. In another embodiment, the firstend of the suture is received in the channel and the channel is closedor crimped to secure the suture therein.

In accordance with another aspect of the present invention, there isprovided a method that includes the steps of forming a plurality ofopenings in the skin, providing a threading device that includes anelongated rod having first and second ends and a suture permanentlyattached thereto, inserting the first end of the elongated rod through afirst opening in the patient's skin, passing the first end of theelongated rod subcutaneously to a second opening in the patient's skin,pulling the first end of the elongated rod and a portion of the suturethrough the second opening, and without turning the elongated rodaround, passing the second end of the elongated rod subcutaneously to anopening in the patient's skin. At least one point during the performanceof the method the first end of the elongated rod extends out of thefirst opening and the second end of the elongated rod extends throughthe second opening.

In accordance with another aspect of the present invention, there isprovided a method of performing surgery that includes the steps ofplacing a tape template onto a portion of a patient's skin, marking aplurality of access sites, making an opening to form a mid-line accesssite, performing liposuction, forming a plurality of openings in theskin at the access sites, providing a threading device having a suturepermanently secured thereto, and inserting the threading device andsuture through a plurality of access sites to form a suture matrix underthe skin.

In accordance with yet another aspect of the present invention, there isprovided a lancet or skin puncturing device that includes a handle thathaving a stop member with an upper surface, and a blade having a top anda bottom that extends upwardly from the upper surface of the stopmember. The blade includes at least two portions that meet at an angle,thereby forming a V when viewed from the top. The blade includes atleast two sharp edges each having first and second ends and at least twoblunt edges each having first and second ends. The first ends of thesharp edges meet at a point and extend away from the point downwardly atan angle of 90° or less and not in the same plane. The first ends of thetwo blunt edges extend downwardly from the second ends of the two sharpedges. The angle formed between the corresponding sharp edges and bluntedges is obtuse. The second ends of the two blunt edges are connected tothe stop member.

In accordance with another aspect of the present invention, there isprovided an article of manufacture that includes a handle that includesa stop member having an upper surface, and a blade having a top and abottom extending upwardly from the upper surface of the stop member thatforms an arc when viewed from the top. The blade includes at least twosharp edges each having first and second ends and at least two bluntedges each having first and second ends. The first ends of the sharpedges meet at a point and extend away from the point downwardly. Thefirst ends of the two blunt edges extend downwardly from the second endsof the two sharp edges. The second ends of the two blunt edges areconnected to the stop member.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more readily understood by referring to theaccompanying drawings in which:

FIG. 1 is a perspective view of a tape template in accordance with apreferred embodiment of the present invention;

FIG. 2 is a view of the tape template of FIG. 1 being used to markpuncture locations on a patient's chin;

FIG. 3 is a front elevational view of a lancet in accordance with apreferred embodiment of the present invention;

FIG. 4 is a perspective view of the lancet of FIG. 3;

FIG. 5 is a view of the lancet of FIG. 3 being used to make a puncture;

FIG. 6 is a side elevational view of a handset in accordance with apreferred embodiment of the present invention;

FIG. 7 is a sectional side elevational view of the handset of FIG. 5showing the fiberoptic core;

FIG. 8 is a cross-sectional view of the handset of FIG. 5 before dockingwith a skin port in accordance with a preferred embodiment of thepresent invention;

FIG. 9 is a cross-sectional view showing the skin port inserted througha patient's skin before deployment;

FIG. 10 is a cross-sectional view showing the skin port inserted througha patient's skin after deployment;

FIG. 11 is a perspective view of the skin port;

FIG. 12 is a cross-sectional view of another embodiment of a skin port;

FIG. 13 is a side elevational view of a threading device in accordancewith a preferred embodiment of the present invention;

FIG. 14 is a sectional side elevational view of the threading device ofFIG. 13;

FIG. 15 is a view of the threading device of FIG. 13 being used on apatient;

FIG. 16 is another view of the threading device of FIG. 13 being used ona patient;

FIG. 17 illustrates the threading device of FIG. 13 passing through thesubcutaneous facial ligaments and neurovascular structures.

FIG. 18 is a side elevational view of a knot positioning implement inaccordance with a preferred embodiment of the present invention;

FIG. 19 is a view of a patient with a threaded skin port placed in themidline sub-mental access site and a suture knot extending therethrough;

FIG. 20 is a cross-sectional view of the knot positioning implement ofFIG. 15 pushing the knot through the threaded skin port and under apatient's skin;

FIG. 21 is a side elevational view of a threaded skin port in accordancewith a preferred embodiment of the present invention;

FIG. 22 is a sectional side elevational view of the threaded skin portof FIG. 21;

FIG. 23 is a perspective view of the threaded skin port of FIG. 21;

FIG. 24 is a side elevational view of a fiberoptic suture in accordancewith a preferred embodiment of the present invention;

FIG. 25 is a view of a patient with the support matrix shown in hiddenlines;

FIG. 26 is an exploded perspective view of a laminated tape template inaccordance with a preferred embodiment of the present invention;

FIG. 27 is a view of the laminated tape template of FIG. 26 being usedto mark puncture locations on a patient's chin;

FIG. 28 is a perspective view of a handset in accordance with apreferred embodiment of the present invention;

FIG. 29 is an exploded perspective view of the handset of FIG. 28;

FIG. 30 is a detailed perspective view of the instrument dock of thehandset of FIG. 28;

FIG. 31 is an end view of the handset of FIG. 28;

FIG. 32 is a detailed perspective view of another preferred embodimentof the instrument dock of the handset of FIG. 28;

FIG. 33 is a perspective view of a clearing device secured on the end ofthe handset of FIG. 28;

FIG. 34 is a cross-sectional view taken along line 34-34 of FIG. 33;

FIG. 35 a is a perspective view of another clearing device secured onthe end of the handset of FIG. 28;

FIG. 35 b is a perspective view of another clearing device secured onthe end of the handset of FIG. 28;

FIG. 36 is a perspective view of a threading device in accordance with apreferred embodiment of the present invention;

FIG. 37 is a detailed elevational view of a portion of the threadingdevice of FIG. 36 showing that it is tapered;

FIG. 38 is an exploded perspective view of the threading device of FIG.36;

FIG. 39 is a detailed elevational view of a portion of a threadingdevice that includes an eyelet;

FIG. 40 is a cross-sectional partial elevation of a threading devicewith a self-contained power source and light source in accordance withanother preferred embodiment of the present invention;

FIG. 41 is a perspective view of a threading rod in accordance with apreferred embodiment of the present invention;

FIG. 42 is a detailed perspective view of the threading rod of FIG. 41showing the groove;

FIG. 43 is a cross-sectional elevation of an end of the threading rod ofFIG. 41 taken along line 43-43 of FIG. 41;

FIG. 44 is a perspective view of the threading device of FIG. 36inserted into a handset;

FIG. 45 is a cross-sectional elevation taken along line 45-45 of FIG.44;

FIG. 46 is an exploded perspective view of a handset and clearing devicein accordance with another preferred embodiment of the presentinvention;

FIG. 47 is a cross-sectional elevational view of a handset with aclearing device assembly thereon in accordance with another preferredembodiment of the present invention;

FIG. 48 is a partial cross-sectional elevational view of a handset witha nose cone thereon in accordance with another preferred embodiment ofthe present invention;

FIG. 49 is a perspective view of a threading rod in accordance withanother preferred embodiment of the present invention;

FIG. 50 is a partial cross-sectional elevational view of a handset withthe threading rod of FIG. 49 secured therein;

FIG. 51 is a view of a patient showing the use of a clearing device toclear an access site;

FIG. 52 is a view of a patient showing insertion of the threading rodand first suture into access site 14 a using the handset;

FIG. 53 is a view of a patient showing insertion of the threading rodand first suture into access site 14 b after pivoting the threading rod;

FIG. 54 is a view of a patient showing insertion of the threading rodand second suture into access site 14 a using the handset after theentire first suture has been placed;

FIG. 55 is a view of a patient showing insertion of the threading rodand second suture into access site 14 g after pivoting the threadingrod;

FIG. 56 is a view of a patient showing the final placement of thesupport matrix with two sutures before the knots have been pushedthrough the access sites;

FIG. 57 is a side elevational view of a threading device in accordancewith another preferred embodiment of the present invention;

FIG. 58 is a side elevational view of a threading device in accordancewith another preferred embodiment of the present invention;

FIG. 59 is a perspective view of a threading rod having a suturepermanently attached thereto in accordance with a preferred embodimentof the present invention;

FIG. 60 is a cross-sectional elevational view taken along line 60-60 ofFIG. 59

FIG. 61 is an exploded perspective view of the components of a threadingrod in accordance with a preferred embodiment of the present invention;

FIG. 62 is a cross-sectional elevational view taken along line 62-62 ofFIG. 61

FIG. 63 is a perspective view of the threading rod of FIG. 61 afterassembly;

FIG. 64 is a cross-sectional elevational view taken along line 64-64 ofFIG. 63;

FIG. 65 is a perspective view of another threading rod having a suturepermanently attached thereto in accordance with a preferred embodimentof the present invention;

FIG. 66 is a cross-sectional elevational view taken along line 66-66 ofFIG. 65;

FIG. 67 is a cross-sectional elevational view taken along line 67-67 ofFIG. 66;

FIG. 68 is a perspective view of a lancet in accordance with a preferredembodiment of the present invention;

FIG. 69 is top plan view of the lancet of FIG. 68;

FIG. 70 is a perspective view of another lancet in accordance with apreferred embodiment of the present invention;

FIG. 71 is top plan view of the lancet of FIG. 68;

FIG. 72 is a perspective view of another lancet in accordance with apreferred embodiment of the present invention; and

FIG. 73 is top plan view of the lancet of FIG. 68.

Like numerals refer to like parts throughout the several views of thedrawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Described herein are preferred embodiments of a technique for placing asuture in a person's body. The technique is preferably used in the fieldof plastic surgery and involves several steps which each requirespecific instrumentation.

For exemplary purposes only, described hereinbelow are preferredembodiments wherein the technique and instruments of the presentinvention are used to perform a neck lift, referred to herein asPercutaneous Trampoline Platysmaplasty. However, it will be understoodthat this is not a limitation on the present invention and that thetechnique and instruments can be used as desired by one of ordinaryskill in the art.

The liposuction portion of the procedure is performed without a largeincision under the chin. The placement of the suture support matrix isperformed through several small access sites in the neck area under thejaw. The advantage is that the entire support system can be placedwithout the typical large incision under the chin that is necessary forthe surgeon to see the operative field. In addition the surgery is lessinvasive and does not require an extensive dissection of the skin in thearea under the chin.

The accurate placement of the support suture(s) (also referred to hereinas the support structure or support matrix 200 and is shown in FIGS. 25and 56) will be described herein along with the description of each ofthe individual instruments or devices that may be used in connectionwith such procedure.

As described above, the inventive aspects of the present inventioninvolve the placement of the support matrix 200 and not the actualliposuction technique. Therefore, it will be understood that anyreferences to liposuction techniques herein are only exemplary.

It will be appreciated that terms such as “front,” “back,” “top,”“bottom,” “side,” “right,” “left,” “upwardly” and “downwardly” usedherein are merely for ease of description and refer to the orientationof the components as shown in the figures. It should be understood thatany orientation of the instruments and articles and the componentsthereof described herein is within the scope of the present invention.

Referring to FIGS. 1-2, template tape (or tape members) 10 will bedescribed. In a preferred embodiment, tape 10 is a clear piece of tapewith perforations 12 therethrough that are spaced apart at predeterminedlocations. Tape 10 includes adhesive thereon so that it can be securedto the patient's skin. In an exemplary embodiment, tape 10 is a one inchwide clear tape with about 2 mm circular perforations 12 definedtherethrough that are spaced about every 5 mm along the center of thetape. The perforations 12 are preferably positioned along thelongitudinal center of the tape 10, however this is not a limitation onthe present invention. In another embodiment, tape 10 is not clear. In apreferred embodiment, tape 10 is provided in roll form. However, this isnot a limitation on the present invention.

Tape 10 is used in immediate pre-operative planning to determine theplacement of access sites 14, which will determine the placement of thesupport matrix 200. Tape 10 is used as a guide to help provide properplacement of each suture and its corresponding pivot point (as describedbelow). Perforations 12 are used to mark access sites 14 for thesurgery.

In a preferred embodiment, first and second tape members 10 are placedon each side of the skin overlying the undersurface of the mandible, asis shown in FIG. 2. Preferably, tape 10 is utilized with the patientsitting upright, which allows the natural neck contours to be visible.This is not a limitation on the present invention, however. The surgeonuses tape 10 and the plurality of perforations 12 to develop a surgicalapproach that is individually tailored for each patient, depending onthe correction desired. As those skilled in the art will appreciate,placement of the support matrix 200 will be different for differentpatients depending on the patient's anatomy.

The exemplary 5 mm span between perforations 12 allows placement ofpivot points in close proximity. This results in a dense support matrixallowing elevation of muscle and glandular tissue. For example, pivotpoints may be placed 1-2 cm apart if minimal support is needed. Thoseskilled in the art will be able to make determinations as to where theaccess sites 14 should be located based on the patient's needs. Forexample, as is shown in FIG. 2, the surgeon has only chosen four accesssites 14 on each side.

As shown in FIG. 2, after the tape 10 has been placed and the surgeonhas determined the structure of the support matrix 200, the surgeonmarks skin exposed through the desired perforations 12 with a surgicalmarking pen or the like. These markings 14 indicate the areas thatrequire suture placement to elevate the soft tissue of the neck. In apreferred embodiment, as is shown in FIGS. 2 and 5, the markings 14 madeusing the first tape member 10 are symmetrical to the markings 14 madeusing the second tape member 10.

As will be described below, each of the markings 14 define a location oraccess site that will be punctured to allow subcutaneous access at thatlocation. For simplicity, because each access site is marked and thenpunctured, the access sites, markings and punctures will all be labeled14 herein.

As will be appreciated by those skilled in the art, in areas wheresignificant platysmal banding or glandular ptosis is evident significantsupport will be required. To achieve this, multiple suture strands willbe required. As each area to be elevated is recognized, a correspondingtape perforation 12 is marked 14 to insure that suture placement isaccurate.

As shown in FIGS. 26-27, in another preferred embodiment, the tape 310can be laminated. The laminated tape 310 preferably includes two layers311 and 313. As shown in FIG. 26, the top layer 313 has one set of holesor perforations 313 a and the bottom layer 311 has two sets ofperforations 311 a and 311 b. Perforations 311 a and 313 a in thedifferent layers 311 and 313 are preferably concentric. However, anyamount of overlap between perforations 311 a and 313 a is within thescope of the present invention. This arrangement of perforations helpsthe surgeon when marking the patient.

As will described below, the support matrix 200 is formed similar to theway a shoelace is weaved through a shoe. Therefore, in marking the skinfor the access sites 14, it can be helpful to mark the skin with twodifferent color markers, for example, red and blue (shown as solid andstippled in the figures). Then, when the matrix 200 is created or the“shoe is laced” the surgeon goes from blue marking to blue marking andred marking to red marking (which each have an access site 14 formedtherein, as described below).

In use, the surgeon positions the laminated tape 310 as desired andmarks the perforations (the concentric or double perforations 311 a and313 a) with the first color. Then, the surgeon peels the first or toplayer 313 off, thereby exposing the second set of perforations 311 b.The surgeon then marks the second set of perforations 311 b with adifferent color marker. Tape 310 can also be configured in a rolledform. In another preferred embodiment, a single piece of tape 310 can beused that extends all the way around the jaw line or other location onthe body. This helps align the markings on each side.

It will be understood that tape 10 or 310 is preferably used beforeperforming liposuction or other desired procedure. However, this is nota limitation on the present invention. In another embodiment, tape canbe used after liposuction is performed. In another embodiment, the tapecan be omitted and the surgeon can mark or puncture the skin as desired.

It will appreciated by those skilled in the art that the tape 10 or 310can be used on areas of the body other than the chin. For example, thetape (and the remainder of the procedure described below) can be usedfor a face lift or in the MACS-lift or when placing a neck definingsuture (both described below).

After the desired markings 14 have been made, the patient is ready forliposuction. It will be understood that when the surgical procedure doesnot include liposuction, the markings are made before whatever procedureis being performed. The patients head and neck are prepped and draped ina sterile fashion and local anesthetic is injected into the area underthe chin. A small opening (referred to herein as the midline sub-mentalaccess site) is made in this area. Tumescent fluid is injected into theentire area under the chin, including the neck region. Liposuction isperformed on the entire region. Upon completion, the area is once againinfiltrated with the tumescent fluid. This subcutaneous infusion resultsin the elevation of the skin from the platysma muscle.

With reference to FIGS. 3-5, after completion of liposuction, thepatient is ready for placement of the support matrix 200. A lancet 40 isused to create access sites 14 by puncturing the dermis at the pointsmarked using tape 10 or 310.

As shown in FIG. 3, lancet 40 includes a blade 42 that has two sharpedges 43 that end at a point 44 with two blunt edges 46 therebelow. In apreferred embodiment, blade 42 is about 8 mm in length. Blunt edges 46of blade 42 extend from a flange or stop member 48 that prevents blade42 from going deeper into the skin than desired. Flange 48 ensuresconsistent depth of blade penetration. Also, blade 42 is sized to allowplacement of skin ports 80 as described below.

Stop member 48 has an upper surface 48 a and a lower surface 48 b. Theblade 42 extends upwardly from the upper surface 48 a of the stop member48. As is shown in FIG. 3, the two sharp edges 43 each have first andsecond ends 43 a and 43 b, respectively and the two blunt edges 46 eachhave first and second ends 46 a and 46 b, respectively.

In a preferred embodiment, the first ends 43 a of the sharp edges 43meet at point 44 and extend downwardly from point 44 at an angle of 90°or less. The first ends 46 a of the two blunt edges 46 extend downwardlyfrom the second ends 43 b of the two sharp edges 43. The sharp edges 43and blunt edges 46 meet at an obtuse angle. The second ends 46 b of thetwo blunt edges 46 are connected to the stop member 48, which, in apreferred embodiment, is disc-shaped. However, this is not a limitationon the present invention. In an alternative embodiment, the blade 42 canextend from the stop member 48 at a non-right angle (e.g., an acuteangle).

In a preferred embodiment, lancet 40 includes an attachment member 50that extends downwardly from the lower surface 48 b of the stop member48 and allows the lancet 40 to be secured on a standard scalpel handle52. In another embodiment, lancet 40 can be provided with a unitaryhandle.

FIGS. 68-73 show other embodiments 40 a, 40 b and 40 c of lancets inaccordance with further embodiments of the present invention. All ofthese embodiments are shown unitary with a knurled handle 41. However,it will be understood, that, similar to lancet 40, each of the lancets40 a, 40 b and 40 c can include attachment members 50 for attaching thelancet to a standard scalpel handle.

As shown in FIGS. 68 and 69, lancet 40 a includes a blade 42 having twoportions 42 a and 42 b that meet at an angle, thereby forming a “V”shape. In a preferred embodiment, the angle is less than about 180°, ina more preferred embodiment the angle is between about 60° and about150°, in the most preferred embodiment, the angle is between about 75°and about 105°. The blade 42 includes two sharp edges 43 that end at apoint 44 with two blunt edges 46 therebelow. In a preferred embodiment,blade 42 is about 8 mm in length. Blunt edges 46 of blade 42 extend froma flange or stop member 48 that prevents blade 42 from going deeper intothe skin than desired. Flange 48 ensures consistent depth of bladepenetration.

The blade 42 extends upwardly from the upper surface 48 a of the stopmember 48. As is shown in FIG. 3, the two sharp edges 43 each have firstand second ends 43 a and 43 b, respectively and the two blunt edges 46each have first and second ends 46 a and 46 b, respectively.

In a preferred embodiment, the first ends 43 a of the sharp edges 43meet at point 44 and extend downwardly from point 44 at an angle of 90°or less. The first ends 46 a of the two blunt edges 46 extend downwardlyfrom the second ends 43 b of the two sharp edges 43. The sharp edges 43and blunt edges 46 meet at an obtuse angle. The second ends 46 b of thetwo blunt edges 46 are connected to the stop member 48, which, in apreferred embodiment, is round.

As shown in FIGS. 70 and 71, lancet 40 b is similar to lancet 40 a,however, it includes four portions 42 a-42 d that meet at angles,thereby forming two points 44. This forms an “M” shape when viewed fromabove.

As shown in FIGS. 72 and 73, lancet 40 c is similar to lancet 40,however, the blade 42 is “U” shaped. In a preferred embodiment, theblade is an arc or approximately a half circle or half ellipse in shape.

It will be understood that these various shapes are advantageous forcreating a puncture that is suitable for performing the proceduresdescribed below, however, they minimize scarring as compared to makinglong incisions. Other shapes, such as an “S” can also be used.

The subcutaneous infusion described above results in the elevation ofthe skin from the platysma muscle. Once infiltrated, the access sites 14are developed by puncturing of the skin with the percutaneous lancet 40at the markings developed using tape 10, as shown in FIG. 5. Lancet 40allows puncturing of the skin in order to gain access to the neck regionand preferably ensures that each access site is as small as possible,allowing the placement of the support system 200.

It will be understood that in a preferred embodiment, lancet 40 createspunctures instead of incisions, which minimalizes trauma and the risk ofscarring. However, incisions can be used in another embodiment.

Referring to FIGS. 6-7, the next instrument used in the procedure is ahandset or handle 60. Handset 60 is embodied in a reusable insertiondevice with an instrument dock 64 at an end thereof. In a preferredembodiment, handset 60 also includes a fiber-optic light port 62. In apreferred embodiment, the handset is ergonomically designed to fit intothe surgeon's hand when gripped. However, this is not a limitation onthe present invention. Preferably, handset 60 is made of a metal, suchas stainless steel or titanium. However, it can be made of othermaterials, such as a plastic or the like. As is described below,instrument port 64 is compatible with a number of the instruments thatare used in the inventive surgical procedure. The design structure andform allows right to left hand interchangeability with ease andprecision.

In a preferred embodiment, instrument dock 64 includes an inner threadedsurface or threaded female connector 66 and a larger male connector 68that interlocks with the skin ports 80 (described below) allowingdeployment and illumination. The instrument dock 64 is adapted to dockwith certain instruments, as will be described more fully below. Handset60 will be described more fully below in conjunction with theinstruments with which it is intended to be used.

The fiberoptic light port 62 allows docking with a fiberoptic light cord(not shown). The transmission of fiberoptic light through the handset 60illuminates each device when it is attached to the working end ofinstrument dock 64.

In a preferred embodiment, the handset 60 includes a fiberoptic core 70,which is made up of at least one, and preferably a plurality, offiberoptic strands. When a fiberoptic light cord is connected to lightport 62, the light is transmitted through the fibers and out through anopening 72 that is coaxial with female connector 66.

In another embodiment other types of lighting can be used. For example,LED, incandescent, fluorescent and other light sources can be used.However, it will be understood that the light transmission is not alimitation on the invention. The handset 60 (and associated instruments)can be provided without a fiberoptic core.

Referring to FIGS. 28-34, another embodiment of a handset or lightingdevice 360 is shown. In a preferred embodiment, handset 360 is batteryoperated and disposable.

As shown in FIG. 29, the handset includes a main body portion 359,housing 361, power source(s) 363, light source 365, instrument dock 364and an obturator or clearing device 321 (described more fully below).Preferably the light source 365 is an LED light source 365 a and thepower source 363 includes a plurality of batteries 363 arranged inseries in housing 361. The circuitry for providing power to the lightsource is well known in the art and therefore a description will beomitted. In a preferred embodiment, the handset (in particular, thehousing 361) is generally tubular. In other words, it does not have tohave a circular cross-section; it may be square, oval or other shape.

In a preferred embodiment, the handset 360 is provided with thebatteries 363 therein. In this embodiment, something is used to breakthe circuit so that the batteries are not drained prior to use. Forexample, a thin piece of paper or the like (referred to herein as a ripcord or circuit breaker 369) can be inserted between two batteries 363to keep the circuit open and is then removed at the appropriate time toallow electrical communication between the batteries, thereby closingthe circuit and lighting the light source 365. As shown in FIG. 29, thehousing preferably has a slot 371 defined therein through which rip cord369 extends.

In use, when the surgeon is ready to use the handset 360, he/she pullsthe rip cord to power the LED 365 a and it will then run for apredetermined amount of time (e.g., until the batteries die). It will beunderstood that handset 360 can also be constructed so that it isreusable. For example, those skilled in the art will understand that itcan be designed to be plugged into a typical wall outlet and run on ACpower.

In a preferred embodiment, the power source and light source are sealedoff from the outside of the handset 360. This helps with sterilizationand prevents contamination of the working area.

In another preferred embodiment, instead of using a rip cord, a latchingswitch mechanism can be used for activating the batteries or turning onthe light source. Any method for switching the latching switch mechanismon is within the scope of the present invention. For example, as shownin FIGS. 46 and 47, the handset 360 can include a tail cone or button337 that can be twisted or pressed to switch the device on. Or, a switchcan be located inside female receiver 366. In this embodiment, whenclearing device 321, clearing device assembly 341 or threading rod 300(described below) are inserted into the receiver 366, the switch isswitched and the batteries and LED are activated. For example, the ringlocated next to o-ring 335 in FIG. 46 could be coupled to a magneticallyactivated switch.

Instrument dock 364 and clearing device 321 are described more fullybelow.

FIGS. 8-11 show a skin port 80. In a typical procedure, a plurality ofskin ports 80 are used. In a preferred embodiment, skin ports 80 aredisposable clear plastic sleeves that are each inserted into one of theaccess sites 14 created by lancet 40.

Generally, skin port 80 includes a flange or cuff 82 that has a tube 84that extends from it. One end of the tube or sleeve 84 is inserted intothe puncture 14 in the skin until the flange 82 rests against the outersurface of the skin. The flange 82 and tube 84 cooperate to define atunnel 86 that will provide access to the area under the skin.Preferably, the port 80 is comprised of colored clear plastic. However,the port 80 can also be made of other materials, does not have to beclear and does not have to be colored.

In a preferred embodiment, the handset 60 or 360 is used to deploy eachport 80 through the individual access sites 14. Preferably, the skinports 80 come in a kit, however this is not a limitation on the presentinvention. The handset 60 design allows quick interlocking with the skinport 80 to remove it from the kit. It will be understood that any designthat allows the handset 60 to interlock with or engage the skin port 80so that it can be deployed into the access site 14 is within the scopeof the present invention.

In a preferred embodiment, the port 80 is snap fit onto the maleconnector 68. For example, as shown in FIG. 8, the male connector 68 caninclude a ridge 68 a extending circumferentially therearound thatcooperates with an indented ring 82 a in the flange 82. The ridge 68 aand indented ring 82 a provide a snap fit so that the port 80 is engagedwith the male connector 68 of the handset 60. Other snap fitarrangements are contemplated.

The tube 84 is then inserted through the access site 14. As shown inFIGS. 8-11, in a preferred embodiment, the skin port 80 includes ananchor system that comprises threads 88 on the outer surface of the tube84 and a folding mechanism 90. The folding mechanism 90 preferablyincludes a pair of folding members 90 a that are attached to aninternally threaded ring 90 b that moves up and down the tube 84 onthreads 88.

As is shown in FIG. 8, the male connector 68 includes a plurality ofteeth 68 b on an end thereof that are adapted to interlock with teeth 82b on the port 80. When the port 80 is engaged with the instrument dock64, teeth 68 b engage or mesh with teeth 82 b. After the tube 84 hasbeen inserted through the access site 14, to deploy the foldingmechanism 90, the handset 60 is turned in a clockwise direction (port 80can be designed to deploy in a counter-clockwise direction as well).Because teeth 68 b and 82 b are engaged, the tube 84 turns with handset60 and within flange 82, thereby causing the internally threaded ring 90b to move upwardly along threads 88. As can be seen in FIG. 11, foldingmembers 90 a include a fold crease 90 c. As threaded ring 90 b movesupwardly, the folding members 90 a fold, as shown in FIG. 10, therebyproviding an anchor and preventing port 80 from pulling out of accesssite 14. The folding members 90 a can be disposed in an unfoldedposition (FIG. 9) and a folded position (FIG. 10).

In a preferred embodiment, flange 82 includes a plurality of spikes 94extending downwardly therefrom that burrow into the skin and help anchorthe port 80 in place.

During placement of the port 80, because the handset 60 includes thefiber optic core 70 and the skin port 80 is clear, upon insertion,transcutaneous visualization of the lighted probe tip will allow safedeployment of skin port 80. Because of the anchoring system, as thehandset is withdrawn, the ridge 68 a pulls out of the indented ring 82 aand the skin port 80 is secured in place. In another embodiment, thesurgeon can use his/her thumb to aid in separating the port 80 from theinstrument dock 64.

Preferably, the ports 80 are disposable and are only used for a singlesurgery. It will be understood that the ports are simply used to gainaccess to the surgical field. Therefore, the type of port used is not alimitation on the present invention. Any type of port that providesaccess through the skin is within the scope of the present invention.The transillumination of light gives three dimensional feedback to thesurgeon.

As shown in FIG. 12, in an alternative embodiment, port 96 can have atube 84 that is oriented at a non-right angle with respect to the flange82. For example, tube 84 can be oriented at a 45 degree angle withrespect to the flange.

FIGS. 13-17 show a preferred embodiment of a threading device 100. In apreferred embodiment, threading device 100 is a stainless steelmalleable rod or tube that includes an eyelet 102 defined therein and arounded, blunt tip 104. Preferably, threading device 100 also includes alight guide (which may be a fiberoptic core) 106 allowing illuminationof tip 104. In this embodiment, the tip 104 is preferably made of atranslucent material, such as a plastic that is affixed to the main bodyof the threading device 100. Threading device 100 includes an end 108that is designed to dock with instrument dock 64 or 364 of handset 60 or360. In a preferred embodiment, end 108 is threaded for engagement withfemale connector 66, however, it will be appreciated that end 108 candock with instrument dock 64 in a number of different ways. For example,instrument dock 64 can include a set screw that holds threading device100 in place or some type of snap or press fit can be provided. Inanother embodiment, a clamp or chuck, similar to that on a drill can beused. Also, end 108 can be internally threaded and can dock with anexternally threaded instrument dock. Instrument dock 64 allows quickconnection and disconnection with threading device 100.

In an embodiment where handset 60 includes a fiber-optic light port 62,docking of end 108 (which includes an opening 108 a therein) withinstrument dock 64 allows the transmission of light to tip 104 ofthreading device 100. In another embodiment other types of lighting canbe used. For example, LED, incandescent, fluorescent and other lightsources can be used.

It will be understood that, eyelet 102 is used to secure the suture 150.Eyelet 102 can be located anywhere along threading device 100.

In use, threading device 100 (and suture 150) are inserted through thevarious skin ports 80 and the support matrix 200 is weaved and created.

FIGS. 36-45 show another embodiment of a threading device or rod 300that includes eyelet 302 or groove 303 (referred to herein as a suturetie-off location) at a point that is about midway between the endsthereof. As shown in FIG. 52, in a preferred embodiment, suture 150 istied around threading device 300 and is received in groove 303. Groove303 is preferably defined circumferentially around the outside of device300. However, in another embodiment, the groove only extends partiallyaround the device 300. The device 300 may also have a recess 305 definedtherein in which the knot 150 c is received. This reduces the profile ofthe knot 150 c and helps prevent the knot 150 c from catching onanything (ligaments, skin, suture, etc.) when threading device 300 isused.

As shown in FIG. 38, in a preferred embodiment, threading device 300includes opposite ends or tips 304, tube 307, end caps 304 a and lightguide 306. In another embodiment, threading device 300 is solid. In yetanother embodiment, the tips and light guide can be integral or the tipscan be omitted. The threading device 300 can be solid metal with nolighting capabilities or can be formed completely of a solid (orplurality of components) made of a translucent or light conducting ortransmissive material (such as plastic) so that the entire device lightsup and/or so that the device is more flexible and easier and cheaper tomanufacture. It will be understood that in a preferred embodiment, thatthe ends or tips of the threading rod 300 are blunt. As used herein,blunt means that the ends do not puncture the skin or any other part ofthe patient's anatomy without sufficient force (a force above thattypically used in the procedure described below). As those skilled inthe art will understand, a typical suture needle punctures the skin withvery little pressure or force applied to it. The blunt ends of thepresent threading device 300 (whether flat or convex) do not puncturethe skin when used as described below. However, in another embodiment,the ends can be sharp.

In the embodiment with the eyelet, eyelet 302 may formed so that whenthe knot 150 c is tied therethrough, it is received in a recessedportion (now shown, but similar to recess 305).

In yet another embodiment, a suture 150 and threading device 300 can beformed as a unit. In other words, the suture 150 is permanently attachedto the threading device 300 and the two can be provided to a surgeon asa unit.

Preferably, threading device 300 is malleable. For example, tube 307 canbe made of stainless steel, titanium or other metal. and light guide 306can be made of a plastic (e.g., acrylic, styrene, polycarbonate or thelike) or glass.

In another preferred embodiment, to make threading device 300 even moremalleable (and easier to insert into the access sites 14), tube 307 canbe tapered (or the entire device 300 can be tapered in the case of asolid rod) from the ends to groove 303, eyelet 302 or suture tie-offlocation (as shown in FIGS. 37 and 39). In another embodiment, as isbest shown in FIGS. 41 and 49, the rod tapers from a first location 333a to the left of the groove 303 toward the first end and the rod tapersfrom a second location to the right 333 b of the groove 303 toward thesecond end. Therefore, the rod has a smaller diameter at the first andsecond ends than it does at the first and second locations. As is shownin FIGS. 41-42, excluding groove 303, the area between first and secondlocations 333 a and 333 b has a constant diameter. This prevents stressconcentration in the center of the rod 300 and helps prevent failure ofthe rod during use. It will be understood that the first and secondlocations 333 a and 333 b can be located anywhere along the length ofrod 300.

As shown in FIG. 36, in one preferred embodiment, threading device 300is non-round. For example, it may be hexagonal. In this embodiment, afemale receiver 366 of instrument dock 364 of the handset 360 or 60 hasa corresponding shape. This prevents threading device 300 from rotatingwhen docked. In another embodiment, only the ends of threading device300 are polygonal. It will be understood that any way for keying thethreading rod and preventing it from rotating is within the scope of thepresent invention. To also help prevent threading device 300 from beingpulled out of female receiver 366, the instrument dock can have anelastomeric o-ring 335 therein that provides a friction fit withanything inserted therein.

As shown in FIG. 38, tube 307 is hollow and light guide 306 runs throughit. In one preferred embodiment, the ends 304 of tube 307 are preferablycapped by end caps 304 a. End caps 304 a are preferably hollow, made ofa transparent plastic and preferably include a flange 304 b that isreceived in tube 307 in a press fit arrangement. Caps 304 a can also bethreaded or glued into the ends of tube 307. In a preferred embodiment,end caps 304 a are bullet-shaped and provide total internal reflection.

As shown in FIGS. 41-43, in another preferred embodiment, tube 307 isround, and light guide 306 is flush with the ends 304 of tube 307, andthe recess described above is omitted. This embodiment also includes thetaper locations 333 a and 333 b described above. However, locations 333a and 333 b can be omitted, therefore, providing the tube 307, excludinggroove 303 with a constant diameter. In this embodiment, the caps 304 aare omitted. To secure the light guide 306 in tube 307, the light guide306 can be potted, which is an adhesive that fills the space between thelight guide 306 and the inner diameter of the tube 307. It will beunderstood that the entire light guide 306 or just the ends can bepotted. In this embodiment, the ends 304 of the rod 300 may be ground,polished and buffed to promote light transmission and to make the endsof tube 307 and light guide 306 flush, as shown in FIG. 43. The ends 304can be flat or convex.

As will be appreciated by those skilled in the art, in a preferredembodiment, to promote total internal reflection in the light guide 306,the light guide 306 can be cladded. If a plastic light guide is used,the outside of the light guide 306 can be cladded. If a glass lightguide is used, as is known in the art, the glass billet can be claddedbefore the glass light guide is drawn. The use of cladding is not alimitation on the present invention, however, if it is not used, thepotting compound may detract from the light transmission and make itless efficient.

When threading device 300 is docked with handset 360, light istransmitted through one end 304 of rod 300, through light guide 306 andout the other end 304. In a preferred embodiment, the bottom of femalereceiver 366 has a complementary shape to that of the ends 304, therebyproviding efficient light transmission.

In a preferred embodiment, a high efficiency white LED is used. In thisembodiment, the lighting device 360 may include a DC to DC converter toboost the voltage to the desired level for the high efficiency whiteLED.

It will be understood by those skilled in the art that it is desiredthat the light emitted by the LED is concentrated and emitted at anarrow angle of focus. In a preferred embodiment, the numerical apertureof the light guide 306 is matched as closely as possible by the lightemitted from the LED. This helps maximize the efficiency of the lighttransmission.

As shown in FIG. 40, in another embodiment, threading device 300includes its own power supply 391 and light source 393. In an exemplaryembodiment, the power supply 391 and light source 393 (e.g., LED's) canbe connected by wires 395. In this embodiment, the handset can beomitted. For example, the threading device 300 can include an LED or thelike at each end.

In another embodiment, the handset can reciprocate the threading deviceto help in passing the threading device subcutaneously. Thereciprocating action allows the threading device to pass easily throughfatty tissue, thus creating less collateral damage to blood vessels,nerve structures and other subcutaneous ligaments. This embodiment issimilar to the device for reciprocating a cannula, which is described inU.S. Pat. No. 6,139,518 to Mozsary, which is incorporated in itsentirety by reference herein. In this embodiment, the handset is poweredto reciprocate the threading device back and forth during surgery. Thethreading device can be connected to the handle by a connector that isaffixed to, integrally formed with, or selectively joinable to areciprocating member. In another embodiment, the handset may reciprocateor vibrate the threading device ultrasonically.

FIGS. 33-35 b show different embodiments of the clearing device 321,which is a blunt instrument for probing the puncture or access site andclearing ligaments and other obstructions. Generally, clearing device321 includes a neck (also referred to as the docking portion) 323 and aclearing portion 325. Clearing portion 323 is preferably about the samediameter as threading rod 300, that way they both fit into the accesssites.

As shown in FIGS. 33-34, in one preferred embodiment, clearing portion325 is spiral shaped. This allows the surgeon to insert the clearingportion 325 into the access site 14 and sweep the area under the accesssite clear by rotating the device (see FIG. 51 for a figure depictinguse of the clearing device 321).

In a preferred embodiment, the clearing device 321 snap fits ontohandset 360. To accomplish this, neck 323 and instrument dock 364include corresponding protrusions 327 a and indentations 327 b, as bestshown in FIG. 34. Clearing device 321 is preferably made of plastic,which allows flexibility for the snap fit arrangement, and also allowsclearing device 321 to transilluminate. In use, light is emitted frominstrument dock 364 and transilluminates the clearing device 321. Inanother embodiment, only the tip of the clearing device 321 isilluminated and the remainder of the device is opaque. This helps directthe light to the tip. In another embodiment, clearing device 321 can bemade of metal.

It will be understood that clearing device 321 can be removably affixedto handset 360 in other ways. For example, an arrangement where aportion of neck 323 is received in slots on the handset 360 (or viceversa) and then the clearing device is turned and locked into place canbe utilized. Also, as shown in FIG. 32, a threaded arrangement 329 iswithin the scope of the present invention. Clearing device 321 can alsobe designed to fit on handset 60.

Referring to FIGS. 46-47, another embodiment of a clearing device 321 isshown. In this embodiment, clearing device 321 can be a rod that fits infemale receiver 366, as shown in FIG. 46. In this embodiment, theclearing device 321 includes a neck (or docking portion) 323 and aclearing portion 323. The neck 323 can be keyed (similar to thethreading device, described below) to prevent rotation when insertedinto female receiver 366.

FIGS. 35 a and 35 b show other embodiments of a clearing device withcurved 325 a and straight 325 b clearing portions. These clearingportions can also be included on a clearing device that is received infemale receiver 366 also.

Referring to FIGS. 46-49, another embodiment of a handset 360 is shown.The handset 360 is generally the same as described above. As is shown inthe figures, the instrument dock includes threads 329 and a circularfemale receiver 366. The handset 360 can also include a tail cone 337 asdescribed above. The tail cone 337 can simply be for providing thesurgeon with something to grip when rotating the clearing device or canbe designed to actuate a latching switch for actuating the light source,as described above.

In this embodiment, the device also includes a nose cone 339 that can bethreaded on the instrument dock 364. The nose cone 339 preferablyincludes gripping indentations 339 a and has an axial opening 339 cdefined therethrough that is axially aligned with female receiver 366when nose cone 339 is threaded onto instrument dock 364. The nose cone339 provides a grip for the surgeon when using the handset 360. Thisallows the surgeon to hold the handset similar to the way that one wouldhold a pen.

As shown in FIG. 46 (and as described above), the clearing device 321can have a neck 323 that fits into female receiver 366 and that includesa clearing portion 325 extending therefrom. As shown in FIG. 47, inanother preferred embodiment, the nose cone and clearing device can beformed as a unit, thereby creating a clearing device assembly 341. Inthis embodiment, the neck 323 is inserted into female receiver 366,while the nose cone 339 is threaded onto instrument dock 364simultaneously. O-ring 335 helps secure neck 323 within female receiver366. In this embodiment, clearing portion 325 extends in a curved paththat defines a plane that is approximately perpendicular to thelongitudinal axis of the neck.

As shown in FIG. 47, clearing device assembly 341 can include a lightguide 306 extending therethrough for illuminating the tip. However, thisis not a limitation on the present invention.

In a surgical procedure where clearing device assembly 341 is used, aseparate nose cone 339 b for securing threading rod 300, as shown inFIG. 48, is also preferably used. In use, after clearing device assembly341 has been used to clear the area around the access sites, theclearing device assembly 341 is unscrewed from instrument dock 364 andthen nose cone 339 b is screwed on. Nose cone 339 b includes an o-ring335 therein for helping secure threading rod 300 when inserted intoopening 339 c and female receiver 366, as shown in FIG. 48. In anotherembodiment, nose cone 339 b can be omitted. In yet another embodiment,nose cone 339 b can include means for tightening the threading rodtherein so that it is difficult to pull the threading rod out. Forexample, the nose cone 339 b may include a set screw, chuck, interiorthreads or the like.

As shown in FIGS. 48 and 49, in another preferred embodiment, threadingrod 300 can include securing channels 343 defined circumferentiallytherearound. When inserted into nose cone 339 b or female receiver 366,one of the channels 343 receives o-ring 335, to help secure thethreading rod 300 therein. The channels are located near both endsbecause the threading rod is reversible, as described below. In anotherembodiment, instead of an o-ring, the nose cone 339 b or instrument dock364 (see FIG. 50) may include a metal ring 345 that is received in thechannels 343, which provides a stronger snap fit arrangement than theo-ring.

It will be understood that the length of the threading rod 300 willchange depending upon the type of procedure being performed (and thesize of the patient's anatomy). It is important that the threading rod300 be long enough so that as it is passed subcutaneously as one endemerges from an exit access site 14 that the other end extends out ofthe entry access site 14. For example, in the Percutaneous TrampolinePlatysmaplasty, the threading rod 300 may be about nine inches long.With reference to FIG. 53, this allows one end of the threading rod 300to extend out of access site 14 b and the opposite end to extend out ofaccess site 14 c simultaneously. In the MACS-lift, the threading rod 300does not have to be as long. It should be understood that the threadingdevices 100 and 300 shown in the figures are not to scale.

With reference to FIGS. 57 and 58, in other embodiment, the threadingrod can be curved or bent. For example, as shown in FIG. 57, the ends304 can be curved in different directions. This type of threading rod300 a may be solid or may have a light guide therein. The ends can besharp or blunt. In the embodiment with sharp ends, it may be difficultto transmit light through the ends 304, so an opening 347 can be made inthe tube 307 to allow light to be emitted from a point spaced from theend 304. Threading rod 300 a may be useful for abdominal surgery and maybe thick and less malleable than the embodiments described above tostrengthen the device. As shown in FIG. 58, in another embodiment, thethreading rod 300 b can have ends that curve in the same direction.

As shown in FIGS. 59-64, in another embodiment, the threading rod 300 ccan include a plastic coating 301 on the outside thereof. This coating301 can help secure the suture 150 in place and can be lubricious to aidin passing the threading rod subcutaneously. As shown in FIG. 59, inthis embodiment, suture 150 is unitary with threading rod 300 c. Duringmanufacturing of threading rod 300 c, one end of suture 150 is wrappedaround tube 307 within groove 303. As shown in FIG. 60, it can bewrapped around once, or, as shown in FIGS. 61 and 62, it can be wrappedaround multiple times (with a wider groove 303). The suture 150 can beknotted to hold it in the groove 303. In a preferred embodiment, anadhesive 314 is placed in groove 303 and around the wraps of suture 150to further secure the suture 150 within the groove. In this embodiment,the adhesive 314 sticks between the threads of the suture 150 and to thetube 307.

As shown in FIG. 61, in a preferred embodiment, the plastic coating 301is a shrink tube. During manufacture, after the suture 150 has beensecured in groove 303, the tube 307 is placed inside the plasticcoating/shrink tube 301. The plastic coating/shrink tube 301 has a hole301 a formed therein through which the suture 150 extends. Then, througha vacuum/heating and or chemical process the tube 301 is shrunk ontotube 307, thereby securing the suture 150 and coating the entire tube307 with plastic, as is best shown in FIGS. 60 and 64. Heat shrinkingcan include either gas (such as air), liquid (such as water or alcohol),and solids (such as sand or salt) acting as conductors of heat to theplastic. Other heating methods can include ultrasonic (as in frictionheating) and light activated (such as laser heating or photopolymerization). Also, other methods of shrinking the plastic caninclude chemical shrinking, such as with salts enzymes, acids or bases.Also just aging certain plastics for a time will cause shrinking.

It will be understood that the plastic coating can be applied in otherways and that the vacuum/shrink process is not a limitation on thepresent invention. The end result is a threading rod 300 c with aplastic coating and a unitary suture. As shown in FIG. 59, the threadingrod 300 c can also be provided with a standard suture needle 315thereon.

The threading rod 300 c can be provided with or without a light guide306. In an embodiment where threading rod 300 c includes a light guide306, the ends 304 can be polished or placed in a heated die to provide alens (see FIG. 63) for good light transmission.

FIGS. 65-67 show another embodiment of a threading rod 300 d thatincludes a unitary suture 150. In this embodiment, the tube 307 includesa longitudinally extending channel 380 defined therein that receives acrimp tube 382. The suture 150 extends through the interior of the crimptube 382 and the tube is crimped 382 a at least one location (andpreferably a plurality) to secure the suture 150 therein. The crimp tubeis then secured in place using a plastic shrink tube 301 similar to theone described above. The crimp tube 382 is preferably made of a softmetal or the like. However, this is not a limitation on the presentinvention. As shown in FIGS. 66-67, as a result of channel 380, theopening extending through tube 307 for receiving the light guide 306 maybe off-center. In another embodiment, the light guide 306 can beomitted.

In another embodiment, the crimp tube can be omitted and the first endof the suture 150 can be received in the channel 380 and then thechannel 380 can be crimped or closed to secure the suture 150. Forexample, the cross section of the elongated rod with the channel 380formed therein would look like a horse shoe, and the opening would bepushed shut with a machine tool. This can be done, for example, by coldforming. This embodiment can omit the coating on the rod. Any way ofpermanently securing the first end of the suture to the elongated rod iswithin the scope of the present invention.

It will also be understood that threading rods 300 c and 300 d caninclude any of the features described above with respect to the otherthreading rods (e.g., tapered ends, grooves, O-rings, etc. forattachment to the handset, cladding).

An exemplary construction of a support matrix 200 using threading device100 will now be described. For example, as shown in FIG. 15, after firstend 150 a of the suture 150 is connected to eyelet 102, the handset 60is grasped by the surgeon and the threading device is inserted through afirst skin port 80 a. The lighted tip 104 of threading device 100illuminates the work area and transilluminates through the skin allowingthe surgeon to determine the proper placement of the support matrix 200and the location of the tip 104. As described above, in a preferredembodiment, port 80 is clear for aiding in the passage of the threadingdevice 100. In other words, when the tip 104 of threading device 100gets close to port 80 it will transilluminate.

The threading device 100 is preferably long enough that it can bethreaded from one side of the jaw line to the other such that the tip104 is brought out through a second skin port 80 b on the opposite sideof the jaw from which it was inserted. At this point, the tip 104 isgrasped by the surgeon and the suture 150 is pulled through the areaunder the neck. Then the threading device 100 is disconnected from thehandset 60 allowing the threading device 100 and the suture 150 to bepulled through the second skin port 80 b, as is shown in FIG. 16.

The threading device 100 is then turned and reconnected to the handset60 and is then reinserted through second skin port 80 b and is passedsubcutaneously to the contralateral side exiting through third skin port80 c. The threading device 100 is once again disconnected from thehandset 60 and is reconnected after the threading device and suture 150are pulled through third skin port 80 c.

Next, the threading device 100 is turned and reconnected to the handset60 and is then reinserted through third skin port 80 c and is passedsubcutaneously to the contralateral side exiting through fourth skinport 80 d. At this point, the threading device 100 is once againdisconnected from the handset 60 and is reconnected after the threadingdevice and suture 150 are pulled through fourth skin port 80 d.

The threading device 100 is then turned and reconnected to the handset60 and is then reinserted through fourth skin port 80 d and is passedsubcutaneously to the contralateral side exiting through fifth skin port80 e. At this point, the threading device 100 is once again disconnectedfrom the handset 60 and is reconnected after the threading device andsuture 150 are pulled through fifth skin port 80 e.

Next, the threading device 100 is turned and reconnected to the handset60 and is then reinserted through fifth skin port 80 e and is passedsubcutaneously to the midline sub-mental access site which preferablyincludes a threaded skin port 120 (described more fully hereinbelow).The threading device 100 and first end 150 a of suture 150 are pulledthrough the threaded skin port 122 and the threading device isdisconnected from the handset 60. The first end 150 a of suture 150 isthen cut from and/or untied from the threading device 100.

Now, the second end (or distal end) 150 b of suture 150, which isextending from first skin port 80 a is secured to the eyelet 102 of thethreading device 100 and the threading device 100 is connected to thehandset 60. The handset 60 is grasped by the surgeon and the threadingdevice is inserted through the first skin port 80 a and is passedsubcutaneously to the contralateral side exiting through sixth skin port80 f. At this point, the threading device 100 is once again disconnectedfrom the handset 60 and is reconnected after the threading device andsuture 150 are pulled through sixth skin port 80 f.

Next, the threading device 100 is turned and reconnected to the handset60 and is then reinserted through sixth skin port 80 f and is passedsubcutaneously to the contralateral side exiting through seventh skinport 80 g. At this point, the threading device 100 is once againdisconnected from the handset 60 and is reconnected after the threadingdevice and suture 150 are pulled through seventh skin port 80 g.

The threading device 100 is then turned and reconnected to the handset60 and is then reinserted through seventh skin port 80 f and is passedsubcutaneously to the contralateral side exiting through eighth skinport 80 h. At this point, the threading device 100 is once againdisconnected from the handset 60 and is reconnected after the threadingdevice and suture 150 are pulled through eighth skin port 80 h.

Next, the threading device 100 is turned and reconnected to the handset60 and is then reinserted through eighth skin port 80 h and is passedsubcutaneously to the threaded skin port 120 at the midline sub-mentalaccess site. The threading device 100 and second end 150 b of suture 150are pulled through the threaded skin port 120 and the threading deviceis disconnected from the handset 60.

As will be understood by those skilled in the art, the tube 84 on theskin ports 80 is long enough that when the threading device 100 isinserted therethrough the suture 150 will anchor itself by encirclingthe facial retaining ligaments during the procedure described above.Preferably, each time the threading device 100 and suture 150 are passedthrough a port 80, the suture is secured on the facial retainingligaments, thereby creating an anchor or pivot point.

It will be understood that the number of access sites 14, ports 80and/or passes, etc. described above are merely exemplary and any numbercan be used in the presently described procedure, as required by theparticular surgery.

Transcutaneous light transmission from the tip 104 of the threadingdevice 100 gives feedback allowing the surgeon to determine the locationof the tip 104 as the support matrix 200 is weaved and created. Thisfeedback allows the placement of each individual strand relative toareas of needed support. This allows placement of the suture strands 150adjacent to the muscle, deep to the skin and fat layers.

Preferably, in each port 80, the end of the tube 84 that is associatedwith the flange 82 has a beveled or tapered edge 84 a, which helpsprevent the tip 104 of the threading device 100 from catching inside thetunnel 86, during insertion.

In another embodiment, two threading devices 100 that are each connectedto an opposite end of the suture 150 can be used. In this embodiment thefirst threading device 100 does not have to be disconnected from the endof the suture 150 before the second end of the suture 150 is threadedthrough the skin. In yet another embodiment, the suture 150 can come ina kit with two disposable threading devices 100 attached to the oppositeends 150 a and 150 b. After forming the matrix 200, the threadingdevices 100 can be cut from the suture 150 and then the suture can betied.

FIGS. 19-23 show the threaded skin port 120 used for the midlinesub-mental access site. The threaded skin port 120 is inserted at thesame time as the skin ports 80 described above. However, this is not alimitation on the present invention. The port 120 includes a flange 122having a tube 124 extending therefrom. The tube 124 is preferablythreaded 126. As is shown in FIG. 22, the tube 124 and flange 122cooperate to define a tunnel 128 therethrough. In a preferredembodiment, the portion of the tunnel 128 in the flange 122 includes abeveled or tapered edge 128 a.

In a preferred embodiment, the port 120 includes a pair of handleportions 130 extending upwardly from the flange 122 that aid the surgeonin threading the port 120 into the midline sub-mental access site.However, the handle portions 130 are not a limitation on the presentinvention and can be omitted. It will be understood that any skin portthat allows access through the skin is within the scope of the presentinvention. For example, skin port 80 or something similar can be used atthe midline sub-mental access site. In another embodiment, port 120 canbe used at access site 14. In a preferred embodiment, port 120 is clearfor aiding in the passage of the threading device 100. In other words,when the tip 104 of threading device 100 gets close to the port 120 itwill transilluminate.

In use, the tube 124 is inserted into the midline sub-mental accesssite. The handle portions 130 are grasped and the port 120 is turned sothat the threads 126 are threaded into the skin until the bottom surfaceof the flange 122 rests against the outer surface of the skin.

In another embodiment, a port similar to skin port 80 described above,but somewhat modified can be used for mid-line access. In thisembodiment, the flange includes a threaded interior that engages thethreads on the exterior of the tube. The distal ends of the foldingmembers are connected to a ring that is not internally threaded. Thisring allows the tube to rotate therein, but (because it is notinternally threaded) does not cause the ring to ride up the threads ofthe tube. The opposite ends of the folding members are connected to theflange.

With this configuration, when the tube is rotated (preferably byengagement with the handset or with a surgeon's fingers), the threadedengagement of the exterior of the tube with the interior of the flangecauses the tube to move outwardly (with respect to the interior of apatient's body). This action causes the folding members to fold at thecrease. In use with a patient, in the folded position, the proximal endof the tube is located outside of the patient's body, and the distal endhas moved closer to the flange than it was in the unfolded position.

With reference to FIGS. 18-20, a knot positioning implement 140 is shownand described. After both ends 150 a and 150 b of the suture 150 arethreaded and the support matrix 200 has been created, the two sutureends 150 a and 150 b are brought out through the midline sub-mentalaccess site (through port 120), as is shown in FIG. 19. A single throwknot 150 c is placed (it will be understood that the type of knot is nota limitation on the present invention) and the knot positioningimplement 140 is utilized to set the knot 150 c.

One end 142 of the knot positioning implement 140 (which is preferablythreaded) docks with the handset 60 and the other end 144 is forked. Theforked end 144 is used to push the knot 150 c through the tunnel 128 ofthreaded skin port 120 and under the skin. In a preferred embodiment,the knot positioning implement 140 includes a fiber optic core 152 andan opening 152 a through which light is transmitted to illuminate thework area when placing the knot 150 c.

After the knot 150 c has been pushed through the threaded port 120,threaded port 120 is twisted out of the access site and the other skinports 80 are removed using the handset 60. To do this, the maleconnector 68 is inserted into the port 80 so that the ridge 68 a snapsinto the indented ring 82 a and the teeth 68 b and 82 b engage oneanother. The handset 60 is then twisted, thereby turning tube 84 andcausing the internally threaded ring 90 b to travel back down threads 88and unfolding folding the folding members 90 a. In another embodiment,the ports 80 can be removed by hand.

After atraumatic removal of the ports 80 and 120, steristrips are thenplaced as desired and a neck compression garment is fitted onto thepatient. See FIG. 25 for the final configuration of the exemplarysupport matrix 200.

Another exemplary embodiment of the construction of a support matrix 200will now be described. Please see FIGS. 46-51. In this embodiment,handset 360 and threading device 300 are used. In this example, as shownin FIGS. 51-56 the majority of the access sites 14 are above thesubmandibular border. Because the threading device 300 is generallystraight and needs to travel around the curvature of the jaw, itrequires intermittent access sites 14 under the jaw to allow thethreading rod to be redirected around the curvature of the neck (theexemplary access site showing this is marked 14 a). The surgeon maychoose to use other access sites under the patient's jaw or in otherlocations as needed to allow the threading rod to be redirected. It willbe understood that the procedure for using any of the embodiments thathave a suture permanently attached to the threading rod (e.g., 300 c or300 d) is the same as described below for threading device 300, but,that when the second suture is used, a second threading device andsuture will have to be used.

As shown in FIG. 51, before using the threading device, the surgeon maywant to use clearing device 321 (or clearing device assembly 341) toclear dermal attachments under the area adjacent the access sites 14.Although not shown in the FIGS. 51-56, the surgeon can also use nosecone 339 or 339 b to help secure the threading rod 300 and aid in themanipulation of the handset 360 during surgery.

For the initial entry of the threading device 300 (or threading devices300 a, 300 b, 300 c or 300 d) and first suture 150 the surgeon createsan access site 14 a under the chin. The handset 360 is illuminated(e.g., by pulling the rip cord, twisting or pushing the tail cone orotherwise switching the light source on) and the threading device 300 isinserted into the handset 360. Threading device 300 is inserted throughaccess site 14 a, as shown in FIG. 52. The lighted tip 304 of threadingdevice 300 illuminates the work area and transilluminates through theskin allowing the surgeon to determine the proper placement of thesupport matrix 200 and the location of the tip 304.

The threading rod is then brought out through a second access site 14 band a portion of the suture is pulled through second access site 14 b.Enough of the suture is pulled through second access site 14 b so thatjust enough of the suture is still sticking out of site 14 a so that thesuture can be tied off at the end of the procedure (described below). Toprevent the end of the suture from being pulled into first access site14 a it can be anchored by something, such as a hemostat. It will beunderstood that because the suture is tied in the middle of thethreading rod 300, the surgeon does not have to pull the entirethreading rod out of the access site. Instead, after over half of thethreading rod is pulled through the site and the suture is pulledthrough, the surgeon can pivot the rod in the desired direction and thenstart pushing the rod back through the access site. This action allowsthe suture to anchor on the ligaments under the skin near the accesssite. It will be understood that because the threading rod 300 has thesuture attached near the middle thereof and it is double ended, it doesnot have to be turned around each time it is brought out from under thepatient's skin. However, the surgeon may turn the threading rod aroundas desired.

Before pushing the threading rod back into second access site 14 b, thesurgeon places the handset on the end of the threading rod to illuminatethe tip 304, as shown in FIG. 53.

The threading rod is then threaded from site 14 b to site 14 a, ispivoted around and is passed subcutaneously to third access site 14 c.Depending on the patient, the surgeon may thread straight from site 14 bto site 14 c without pivoting the rod at 14 a. This is repeated forfourth, fifth and sixth access sites 14 d, 14 e and 14 f and eventuallythe threading rod is brought out through the sub-mental access site(each time, the surgeon does not always have to come back out throughsite 14 a but may go directly to the next site in the “shoe lace”). Itwill be understood that the handset is taken on and off of the threadingrod as desired during this procedure so that one of the tips 304 is litas desired. The suture 150 is then cut from the threading rod.Preferably, each time the threading device and suture 150 are passedthrough an access point 14, the first suture 150 is passed around thefacial retaining ligaments adjacent thereto, thereby creating an anchoror pivot point.

As shown in FIG. 54, a second suture 151 is then tied to the threadingrod 300 and the threading rod is inserted into first access site 14 a.In a procedure where a threading rod having a suture permanentlyattached thereto is used (such as threading rods 300 c or 300 d), a newthreading rod and unitary suture are provided. It is then passedsubcutaneously to seventh access site 14 g. Similar to the proceduredescribed above for the first suture 150 (or the first threading device300 c or 300 d), the second suture 151 (or second threading device 300 cor 300 d) is then threaded to eighth, ninth, tenth and eleventh accesssites 14 h, 14 i, 14 j and 14 k (see FIG. 55) and is finally brought outof the midline sub-mental access site. The ends of the sutures 150 and151 extending out of site 14 a are then tied together, thereby,completing the matrix 200 (see FIG. 56). The knot 150 c is then pushedthrough the site 14 a and under the skin (e.g., using the clearingdevice or threading rod). At this point, the surgeon can pull on theends of the sutures 150 and 151 extending out of the sub-mental accesssite to place the desired tension on the matrix 200. Once this is done,the ends of the sutures 150 and 151 are tied together and the knot 150 cis pushed through the site and under the skin.

It will be understood that the surgery can be performed without thehandset. Some surgeons may want to use the threading device alonewithout using the handset to illuminate the tips. In this situation asolid threading device, a threading device without the light guide or athreading device with self-contained power and light sources can beused. It will be further understood that the threading device 300 can beused for other types of surgery. For example, it can be used to placesuture systems that are commonly utilized in plastic surgery thatpreviously required the opening or elevation of the facial, neck skinand/or other areas of the body. Examples of this include the use of thisdevice or system for placement of a neck defining suture or it can beused in the MACS-lift (minimal access cranial suspension), which isdescribed in The MACS-lift Short Scar Rhytidectomy by Patrick Tonnard,M.D. and Alexis Merpaile, M.D., Aesthetic Surgery Journal, Volume 27,Number 2, pgs. 188-198, March/April 2007, which is incorporated byreference in its entirety herein. In this procedure, “purse-string”sutures are used. To place the sutures, the surgeon could use thethreading rod 300 instead of making the incisions that are typicallymade.

The neck defining suture, as it is known in the art, is described in thearticle Suture Suspension Platysmaplasty for Neck RejuvenationRevisited: Technical Fine Points for Improving Outcomes by VincentGiampapa, M.D., Ioannis Bitzos, M.D., Oscar Ramirez, M.D., and MarkGranick, M.D., Aesthetic Plastic Surgery, Vol. 29, pgs. 341-350, 2005.,which is incorporated by reference in its entirety herein. However,instead of having to make large incisions and elevating the skin underthe neck region, the procedure can be performed by making a smallincision behind the ears and then threading the suture subcutaneouslyunder the mandible using the threading rod 300 and necessary pivotpoints (access sites) as desired.

In a preferred embodiment, the suture that is used in the procedure is a4.0 braided polyester suture. In a more preferred embodiment, as shownin FIG. 24, the suture design contains at least one fiberoptic strand150 d intertwined with the non-fiberoptic strands. The suture 150 isbraided as is known in the art with one, two or three fiberoptic strandsand one or two non-fiberoptic strands, as is desired. This aids in thetransillumination of the suture 150 to check subcutaneous placementafter the suture 150 has been placed. The fiberoptic strand 150 d willilluminate when the handset 60 fiberoptic light coupled with the knotplacement implement 140 is approximated to the suture during tying.Light transmitted to the suture allows the surgeon to visualizeplacement of the support matrix 200 as it is secured. The non-fiberopticstrands can be made of any material known in the art, such as nylon,polypropylene, or other non-absorbable material.

At any point during the creation of the support matrix 200, sutureplacement can be confirmed by placing the handset 60 or 360 (or anylight source) at one of the ends 150 a or 150 b of the suture 150,thereby transmitting light down the fiberoptic strand 150 d to checkplacement of the suture 150.

The illumination of the suture pathway allows the surgeon to determinethe location of the suture. Overall, suture illumination gives thesurgeon feedback relating to the anatomical movement of each pivotpoint.

It will be appreciated by those skilled in the art that the fiberopticsuture can be utilized in all areas of surgery or other materials wherea lit binding material is needed, and not just in the techniquedescribed herein. In another embodiment, the threading device may be astraight or curved needle. Application of light energy during a surgicalprocedure will confirm suture placement and accuracy. Application oflight post-operatively could allow surgeons to understand the evolutionof suture placement related to time and aging.

In an alternative embodiment, the neck skin can be elevated from theplatysma muscle via an incision similar to that used in the standardprocedure discussed above to allow the surgeon to visualize theoperative field and then the suture matrix can be placed through theports 80 and/or access sites 14.

It is contemplated that the above described instruments can be sold inkits. For example, a kit with all or any combination of the instruments,including the tape 10 or 310, a marking pen, lancet 40, handset 60 or360, skin ports 80, threading device 100 or 300, threaded skin port 120,knot positioning implement 140, suture 150 or 151, nose cone 339 or 339,clearing device 321, clearing device assembly 341 or any otherinstrument described herein can be sold.

The embodiments described above are exemplary embodiments of the presentinvention. Those skilled in the art may now make numerous uses of, anddepartures from, the above-described embodiments without departing fromthe inventive concepts disclosed herein. Accordingly, the presentinvention is to be defined solely by the scope of the following claims.

1. A threading device comprising: an elongated tube, wherein theelongated tube has first and second opposite ends and an opening definedtherein, a suture having first and second opposite ends, wherein thefirst end of the suture is secured in the opening defined in the tube, atranslucent light guide extending through the elongated tube, therebyallowing light to be transmitted through the material comprising thelight guide from one end of the tube to the other, wherein the openingis disposed at a location that is approximately halfway between thefirst and second ends.
 2. The threading device of claim 1 wherein theopening is disposed at a location that is approximately halfway betweenthe first and second ends.
 3. The threading device of claim 2 whereinthe diameter of the elongated tube at or near the first end isapproximately the same as the diameter of the elongated rod at or nearthe second end.
 4. The threading device of claim 1 wherein the lightguide includes ends that extend outside of the elongated rod.
 5. Thethreading device of claim 4 wherein the ends are bullet-shaped.
 6. Thethreading device of claim 1 wherein the outside diameter of the rodtapers from a first location to the left of the center of the rod towardthe first end and the outside diameter of the rod tapers from a secondlocation to the right of the center of the rod toward the second end,such that the rod has a smaller diameter at the first and second endsthan it does at the first and second locations.
 7. A threading devicefor performing plastic surgery, the threading device comprising: anelongated tube having first and second open ends and an opening disposedapproximately halfway between the first and second ends, wherein thediameter of the elongated tube at or near the first end is approximatelythe same as the diameter of the elongated tube at or near the secondend, a translucent light guide extending through the elongated tube,wherein the light guide allowing light to be transmitted through thematerial comprising the light guide, wherein the light guide has firstand second ends and wherein the first and second ends of the light guideeach include a blunt translucent tip, and a suture received in theopening and secured within the elongated tube.
 8. The threading deviceof claim 7 wherein the ends are bullet-shaped.
 9. A threading device forperforming plastic surgery, the threading device comprising an elongatedtube having first and second opposite ends, the diameter of theelongated tube at or near the first end being approximately the same asthe diameter of the elongated tube at or near the second end, atranslucent light guide having first and second opposite blunt endsextending through the elongated tube, wherein the first and second endsof the light guide each include a translucent tip, wherein light can betransmitted through the material comprising the light guide and a suturepermanently secured within the elongated tube.
 10. The threading deviceof claim 9 wherein the suture is secured to the elongated tubeapproximately halfway between the first and second ends of the elongatedtube.
 11. The threading device of claim 9 wherein the ends arebullet-shaped.